Sonographic Visibility of Breast Biopsy Marker Clips Up to 4 Weeks After Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00548392
Recruitment Status : Completed
First Posted : October 24, 2007
Last Update Posted : December 31, 2008
Ethicon Endo-Surgery
GE Healthcare
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:
The purpose of this study is to determine how long collagen based marker clips remain visible by ultrasound after placement in suspicious breast lesions and if collagen based marker clips can be reliably identified in the operating room and serve as effective guidance for surgical removal of high risk or malignant breast lesions.

Condition or disease
Breast Cancer

Detailed Description:

Many breast cancers and other breast lesions are discovered as a palpable abnormality by patients or their providers during a breast exam. Diagnostic imaging and biopsy of these lesions may reveal high-risk or malignant findings. These palpable lesions can be removed in the operating room by the surgeon using touch as guidance. However, there are many lesions discovered by screening examinations that surgeons cannot palpate. When this occurs, a radiologist will percutaneously place a wire or wires at the site of the breast lesion using sonographic or mammographic guidance. The surgeon then uses the wires as a guide for complete and successful resection of the lesion.

New marker devices have been developed that are sonographically visible. They consist of the standard mammographically visible metallic clip surrounded by a sonographically visible collagen plug. It is hypothesized that radiologists and surgeons can effectively localize the clip with intra-operative ultrasound and then resect the lesion. If so, the pre-operative wire localization procedure could be eliminated. This could improve the patient experience while saving time and money by reducing the number of invasive procedures from 3 (biopsy, wire-localization and operation) to 2 (biopsy and operation).

Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sonographic Visibility of Breast Biopsy Marker Clips Up to 4 Weeks After Placement
Study Start Date : May 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Primary Outcome Measures :
  1. Visibility of marker clip after placement in suspicious breast lesions. [ Time Frame: Within 4 weeks of placement ]

Biospecimen Retention:   None Retained
none/not applicable

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
outpatient clinic

Inclusion Criteria:

  • Patients with suspicious breast lesions that have undergone biopsy and marker clip placement within 28 days (4 weeks) of pre-operative consultation visit.
  • Patients or their legal representative must be able to provide written informed consent.
  • Patients must be over 18 years old.

Exclusion Criteria:

  • Under the age of 18 years
  • Unable to give written informed consent
  • Patients will be excluded if the clip was placed more than 4 weeks prior to their pre-operative appointment or wire-localization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00548392

United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Ethicon Endo-Surgery
GE Healthcare
Principal Investigator: Peter R Eby, MD University of Washington

Responsible Party: Peter Eby, University of Washington/SCCA Identifier: NCT00548392     History of Changes
Other Study ID Numbers: 6263
First Posted: October 24, 2007    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: December 2008

Keywords provided by Fred Hutchinson Cancer Research Center:
high risk
marker clip